PHA position on Stem Cell Therapy

• Responding to the growing interest on stem cell therapy (SCT) for heart disease, the Philippine Heart Association recently held an Intercouncil Summit on Stem Cell Therapy in Heart Disease to gather and present objective data on this cell-based therapy in heart disease.

• An extensive review of clinical trials on SCT in patients with acute myocardial infarction (AMI) and left ventricular dysfunction (LVD) was performed. Based on three systematic reviews (most notably involving The Cochrane Library 2012 ) involving 33 randomized controlled trials, bone marrow SCT showed no effect in reducing mortality and morbidity after AMI during short term (six months) and long-term follow ups (1-5 years) over conventional treatment such as angioplasty.

• However, bone marrow SCT improved short-term and long-term left ventricular function (or LV function) and reduced left heart size (LVESV, LVEDV), infarct size and cardiac wall motion. These findings seem very promising. In general, the studies were underpowered to detect changes in clinical outcomes (especially adverse events) since the sample sizes were small. The lack of association with an increase in adverse events is not an assurance of its safety. Thus, larger clinical trials are needed before recommending this intervention for routine clinical use.

• There are no published clinical trials with rigorous methodology which used sheep's stem cell for human use in heart disease.

• Therefore, in the light of all these data, the PHA does not recommend SCT of any kind (from bone marrow, adipose tissues and non-human sources) as a standard of care to reduce cardiovascular risk in patients with heart disease (coronary heart disease and heart failure).

• This conclusion is basically aligned with the pronouncements of the Department of Health that such treatment should be considered "highly investigational for compassionate use".

• PHA supports ethically conducted research studies that will help shed light on some of the uncertainties regarding this modality before it can be recommended as a standard of care in heart disease. This basically acknowledges that more studies with robust designs are needed to further elucidate on the role of SCT as a strategy for heart disease.

(N.B. This statement shall be reviewed periodically when new scientific evidences become available.)